Market Place
Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring
New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on
January 3, 2019. After factoring
in debt, the deal value ballooned to about US$ 95 billion, which according
to data compiled by Refinitiv, made it the largest healthcare deal on
record.
In the summer, AbbVie Inc,
which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic
treatments, for US$ 63 billion. While the companies are still awaiting
regulatory approval for their deal, with US$ 49 billion in combined 2019
revenues, the merged entity would rank amongst the biggest in the industry.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
The big five by pharmaceutical sales — Pfizer,
Roche, J&J, Novartis and Merck
Pfizer
continued
to lead companies by pharmaceutical sales by reporting annual 2019 revenues of
US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to
2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019,
which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in
2019.
In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches.
Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with
Mylan, there weren’t any other big ticket deals which were announced.
The
Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020
revenues between US$ 19 and US$ 20 billion
and could outpace Teva to
become the largest generic company in the world, in term of revenues.
Novartis, which had
followed Pfizer with the second largest revenues in the pharmaceutical industry
in 2018, reported its first full year earnings after spinning off its Alcon eye
care devices business division that
had US$ 7.15 billion in 2018 sales.
In 2019,
Novartis slipped two spots in the ranking after reporting total sales of US$
47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New
Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7
billion to acquire a late-stage cholesterol-lowering
therapy named inclisiran.
As Takeda Pharmaceutical Co was
busy in 2019 on working to reduce its debt burden incurred due to its US$ 62
billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased
the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion.
Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the
gene-therapy maker Novartis had acquired for US$ 8.7 billion.
The deal gave Novartis rights to Zolgensma,
a novel treatment intended for children less than two years of age with the
most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million,
Zolgensma is currently the world’s most expensive drug.
However,
in a shocking announcement, a month after approving the drug, the US Food and
Drug Administration (FDA) issued a press release on
data accuracy issues as the agency was informed by AveXis that
its personnel had manipulated data which
the FDA used to evaluate product comparability and nonclinical (animal)
pharmacology as part of the biologics license application (BLA), which was
submitted and reviewed by the FDA.
With US$
50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker
Roche came in at number two position in 2019
as its sales grew 11 percent driven by
its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta.
Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin.
In late 2019, after months of increased
antitrust scrutiny, Roche completed
its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in
gene therapy.
Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.
Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list.
While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga.
US-headquartered Merck, which is known as
MSD (short for Merck Sharp & Dohme) outside the United States and
Canada, is set to significantly move up the rankings next year fueled by its
cancer drug Keytruda, which witnessed a 55
percent increase in sales to US$ 11.1 billion.
Merck reported total revenues of US$ 41.75 billion and also
announced it will spin off its women’s health drugs,
biosimilar drugs and older products to create a new pharmaceutical
company with US$ 6.5 billion in annual revenues.
The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Humira holds on to remain world’s best-selling drug
AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for
the company. AbbVie has failed to successfully acquire or develop a major new
product to replace the sales generated by its flagship drug.
In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due
to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion.
Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position
and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018.
While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9
billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda.
Keytruda took the number three spot in drug sales that
previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion.
Cancer treatment Imbruvica, which is marketed
by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1
billion in 2019 revenues, it took the number five position.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Vaccines – Covid-19 turns competitors into partners
This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.
GSK reported the highest vaccine sales of all drugmakers with
total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its
total sales of US$ 41.8 billion (GBP 33.754 billion).
US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo.
This is the first FDA-authorized vaccine against the deadly virus which causes
hemorrhagic fever and spreads from person to person through direct contact with
body fluids.
Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4
billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently
pushed drugmakers to move faster than ever before and has also converted
competitors into partners.
In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus.
The two companies plan to start human trials
in the second half of this year, and if things go right, they will file
for potential approvals by the second half of 2021.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Our view
Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.
Our compilation shows that vaccines and drugs
for infectious diseases currently form a tiny fraction of the total sales of
pharmaceutical companies and few drugs against infectious diseases rank high on
the sales list.
This could well explain the limited range of
options currently available to fight Covid-19. With the pandemic currently infecting
over 3 million people spread across more than 200 countries, we can safely
conclude that the scenario in 2020 will change substantially. And so should our
compilation of top drugs for the year.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Impressions: 54752
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
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The year 2017 was a landmark year for pharmaceutical
industries in the US and Europe, with a sharp increase in the number of new molecular entities (NMEs) being approved in both geographies.
The US Food
and Drug Administration (USFDA) approved 46 NMEs in 2017, the second highest
since 1996 when 53 NMEs were approved. In Europe, the European Medicines Agency
(EMA) approved 35 drugs with a new active substance, up from 27 in 2016.
Sales for most major pharmaceutical
companies continued to grow in 2017. Earnings forecasts for 2018 have been raised due to the recent US tax reform that has
generated investor hopes for accelerated dividend growth and share buyback
plans.
This week, PharmaCompass brings
you a compilation of the top drugs of 2017 by sales revenue.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Top-sellers: Humira races ahead, despite launch of biosimilars; Enbrel a distant second
There wasn’t any upheaval
at the top of the pharma drug sales charts. AbbVie’s anti-TNF (tumor necrosis factor) giant
Humira (adalimumab), which is approved to treat
psoriasis and rheumatoid arthritis, added
almost another US $3 billion to its 2016 sales and posted nearly US $19 billion in revenues.
Last year, AbbVie’s raised expectations for Humira’s earnings to reach US $21 billion in global sales by 2020. The
company believes this drug will continue to be a significant cash contributor
until 2025 and the US $21 billion sales forecast
by 2020 is about US $3 billion higher than its expectation two years ago.
In 2016, the US Food and Drug Administration
(FDA) approved Amgen’s Amjevita (adalimumab-atto) — a biosimilar of Humira. And in 2017, another Humira biosimilar — Boehringer Ingelheim’s Cyltezo
(adalimumab-adbm) — received approval from the FDA and European authorities.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Enbrel (etanercept),
the longest-used biologic medicine for the treatment of rheumatism around the
world, was the second best-selling drug with US $8.262 billion in 2017 sales.
The sales of the drug were down from US $9.366 billion in
2016 owing to lower selling prices and increased
competition, which in turn hurt demand.
Since it was first approved in the United States in 1998,
Enbrel has been approved in over 100 countries and the drug is promoted by Amgen,
Pfizer
and Takeda
in different geographies.
Novartis’ biosimilar copy of Enbrel, which got approved by the FDA in August
2016 for the treatment of patients with
rheumatoid arthritis (RA), plaque psoriasis, ankylosing spondylitis (AS) and
other diseases is still not on the market because of a patent-protection
challenge from Amgen.
Amgen is arguing in the US federal court
that its drug has patent protection until 2029.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Fast-growing drugs: Eylea and Revlimid bring
fortunes for Regeneron and Celgene
Regeneron’s
flagship eye treatment, Eylea (aflibercept) which is marketed by Bayer outside the United States, added another US $1 billion in
annual sales last year to record US $8.260 billion in total sales. Eylea net
sales grew 11 percent year-on-year in the US and 19 percent year-over-year
outside the US.
The company believes much of the recent
growth in the US was driven by demographic trends with an aging population as
well as an overall increase in the prevalence of diabetes.
These demographic trends are expected to
continue in the coming years, providing an opportunity for continued growth.
Eylea sales alone contribute 63 percent to Regeneron’s total sales.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Celgene’s
Revlimid
(lenalidomide)
— a thalidomide derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in an additional US $1.2 billion in 2017 sales and had total revenues of US $8.187 billion.
Revlimid continues to contribute more than 60 percent to the company’s total sales of US $13 billion.
Celgene received a setback this month as the
USFDA refused to consider Celgene’s
application for ozanimod, an experimental
treatment for relapsing multiple sclerosis. The treatment was being seen as a
key to the company’s fortunes as Celgene had
said ozanimod is worth US $4 billion to
US $6
billion a year in peak sales.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Gilead’s Hepatitis C franchise enters free fall
Gilead Sciences’ blockbuster hepatitis C drugs franchise that includes Sovaldi and Harvoni continue to feel the
competitive heat as they registered US $9.137
billion in 2017 sales, down from US $14.834
billion the previous year.
While reporting 2017 results, Gilead provided guidance for
2018 and said its sales of Hepatitis C drugs could fall
further to US $3.5 billion - US $4 billion. At their peak in 2015, Gilead’s Sovaldi and Harvoni had together generated
US $19.1 billion in sales.
One of the major reasons for this drop is AbbVie’s launch of its new treatment Mavyret
at a deep price discount to the competition. AbbVie
also claims to have the shortest treatment course at eight weeks, compared with
12 weeks or longer for other treatments.
AbbVie reported US $1.274 billion in Hepatitis C drug sales
in 2017, down from US $1.522 billion in 2016.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Novartis’ Gleevec, Merck’s cardiovascular drugs, GSK’s Advair face generic heat
Novartis’ Gleevec (imatinib), which had at one point become the best-selling drug for Novartis and had brought in US $3.323 billion for the company in 2016, started facing generic competition last year and the anti-cancer drug lost US $1.380 billion in sales to bring in ‘only’ US $1.943 billion last year.
The US patents of Merck’s cardiovascular drugs — Zetia (Ezetimibe)
and Vytorin (Ezetimibe
and Simvastatin) — expired in April 2017. In May 2010, Merck and Glenmark
Pharmaceuticals entered into an agreement that allowed Glenmark to launch
a generic version of Zetia in late 2016. The drugs
that had combined sales of US $3.701
billion in 2016 felt the generic heat in 2017 and the sales were US
$1.606 billion lower at US $2.095
billion.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
GSK’s Advair, which was expected
to encounter generic competition in 2017, continued to breathe easy as the FDA
found deficiencies in the applications of Hikma, Mylan and Sandoz.
All three failed to get the FDA nod for their generic versions of Advair, a drug used in the management of asthma and chronic obstructive pulmonary disease that generated sales worth US $4.431 billion (£3.130 billion) in 2017.
Top 15 drugs by sales
Here is PharmaCompass’ compilation
of the best-selling drugs of 2017. This is based on information extracted from
annual reports and US Securities and Exchange Commission (SEC) filings of major
pharmaceutical companies.
If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version.
Click here to access all the 2017 data (Excel
version available) for FREE!
S. No.
Company / Companies
Product Name
Active Ingredient
Main Therapeutic Indication
2017 Revenue in Millions (USD)
1
AbbVie Inc., Eisai
Humira®
Adalimumab
Immunology (Organ Transplant, Arthritis etc.)
18,946
2
Amgen, Pfizer Inc., Takeda
Enbrel®
Etanercept
Immunology (Organ Transplant, Arthritis etc.)
8,262
3
Regeneron, Bayer
Eylea
Aflibercept
Ophthalmology
8,260
4
Celgene
Revlimid
Lenalidomide
Oncology
8,187
5
Roche
MabThera®/Rituxan®
Rituximab
Oncology
7,831
6
Johnson & Johnson, Merck, Mitsubishi Tanabe
Remicade®
Infliximab
Autoimmune Disorders
7,784
7
Roche
Herceptin®
Trastuzumab
Oncology
7,435
8
Bristol-Myers Squibb, Pfizer Inc.
Eliquis®
Apixaban
Cardiovascular Diseases
7,395
9
Roche
Avastin®
Bevacizumab
Oncology
7,089
10
Bayer, Johnson & Johnson
XareltoTM
Rivaroxaban
Cardiovascular Diseases
6,590
11
Bristol Myers Squibb, Ono Pharmaceutical
Opdivo
Nivolumab
Oncology
5,815
12
Sanofi
Lantus
Insulin Glargine
Diabetes
5,731
13
Pfizer Inc.
Prevnar 13/Prevenar 13
Pneumococcal 7-Valent Conjugate
Anti-bacterial
5,601
14
Pfizer Inc., Eisai
Lyrica
Pregabalin
Neurological/Mental Disorders
5,318
15
Amgen, Kyowa Hakko Kirin
Neulasta®
Pegfilgrastim
Blood Disorders
4,553
Sign up, stay ahead
In order to stay informed, and receive
industry updates along with our data compilations, do sign up for the PharmaCompass Newsletter and
you will receive updated information as it becomes available along with a lot
more industry analysis.
Click here to Access All
the 2017 Data (Excel version available) for FREE!
Impressions: 58406
https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-in-2017-who-sold-the-blockbuster-drugs
#PharmaFlow by PHARMACOMPASS
29 Mar 2018
This week in Phispers, we tell you how Amsterdam became EU’s choice for hosting the EMA. As Biocon receives an inspection closure from the FDA for its Bengaluru sterile injectables facility, we analyze how news reports on Biocon and Mylan moving a step closure to getting an FDA nod for its Herceptin biosimilar could be misplaced. We also bring you news on the positive trials from Roche and the Skype ban in China. Meanwhile, Concordia got into yet another drug price hike controversy. This time for its thyroid drug — liothyronine.
Lucky draw gets Brexit-struck EMA a new home in Amsterdam
The biggest news from the world of pharmaceuticals this week
was the decision to relocate the European Medicines Agency (EMA), with nearly 900
employees, to Amsterdam (the Netherlands).
The relocation of EMA from London is a consequence of the UK’s withdrawal from the European Union. The agency was not involved in the selection of the new location.
Amsterdam was one of the 19 offers to host the
EMA submitted by the EU member states at the end of July 2017. The EMA now has
just over 16 months to prepare for the move and take up its operations in
Amsterdam by March 30, 2019.
“Amsterdam ticks many of our boxes,” Guido
Rasi,
executive director, EMA said. “It offers excellent connectivity and a building that can be shaped according to our needs,” Rasi added.
The decision was made by closed ballot votes from each EU member state held in Brussels this week. An EMA survey of its staff found most of them might quit if posted to the bloc’s poor eastern regions. The employees had rated Amsterdam, Barcelona and Vienna as the top choices, while Warsaw, Poland, Bucharest, Romania, and Sofia, Bulgaria were rated the lowest.
Milan, Amsterdam and Barcelona campaigned hard. But there was
a push from eastern states, as Slovak capital Bratislava turned out to
be a strong contender.
In the first round, Milan (with 25 votes), Copenhagen and
Amsterdam (with 20 votes each) advanced out. Bratislava had 15 votes and
Barcelona had 12 votes.
Milan (with 12 votes) and Amsterdam (with 9 votes) then
proceeded into the third round of voting.
In the final round of voting, Milan and Amsterdam both tied
with 13 votes each. The decision was taken through a draw of lots, that
Amsterdam won.
Biocon gets EIR for sterile injectables facility; FDA nod for its biosimilar still in question
India’s Biocon has received
an EIR (establishment inspection closure) for its sterile injectables facility,
inspected by the US Food and Drug Administration (FDA) earlier this year.
However, contrary to what some recent news reports suggest, the company and its
partner Mylan are not a step
closer to getting an FDA nod for its biosimilar of Roche’s blockbuster cancer drug — Herceptin.
According to these reports, Biocon
and Mylan have resolved FDA concerns about its Bommasandra plant, setting it and Mylan up to potentially win FDA
approval for the first Herceptin biosimilar.
According to PharmaCompass’ analysis, there were two inspections at Biocon — the first one was for the biosimilars (during March 27 to April 7 this year); while the second one
was for their sterile injectables facility (during May 25 to June 3 this year).
Based on the dates shared in Biocon’s statement, the EIR is for the second inspection and there is no ‘exact’ news on the biosimilars inspection.
The location of both inspections is the same — Plot 2-4, Phase IV, in Bommasandra, Bengaluru. However,
there maybe different buildings within the campus that were inspected by the
FDA.
The same location in Bommasandra was also put on Health Canada’s Inspection Tracker list for data-integrity concerns found by a regulatory partner of Health Canada.
According to news reports, the FDA EIR to the sterile plant
comes less than two weeks before the December 3 date that the FDA has set for
considering approval of the Herceptin biosimilar. The original action date was
September 3, but the FDA delayed that for three months after seeking additional
information from Mylan and Biocon. However, in our view, the EIR and the
December 3 date have no correlation.
After
receiving the EIR, the FDA further indicated that Biocon needs to implement the CAPA (corrective
action and preventive action) plan and resubmit the updated details.
Meanwhile, Roche is using all its might to prevent its revenues from getting chewed away by cheaper biosimilars. This week,
Roche Holding sued Pfizer Inc to stop it
from selling a copy of Herceptin in the US.
Boehringer opens the door for crowdsourced research through opnMe.com
Germany’s Boehringer
Ingelheim has launched opnMe.com — a platform that offers free and open access to certain pre-clinical molecules and non-clinical investigation to scientists worldwide.
The opnMe.com
platform provides scientists with many best-in-class
molecules supported by comprehensive data packages on one centralized platform.
It also offers them direct access to molecules for independent research as well
as other molecules for partnering with Boehringer.
Through opnMe.com, molecules for some of the most relevant
targets in biomedical research would be shared. This, in turn, would create
possibilities for further independent and collaborative discovery as well as
the identification of novel treatment approaches for patients.
“Working together with scientists across the world, we can accelerate research in a wide range of biomedical research areas,” Clive R. Wood, PhD, senior corporate vice president, Discovery Research at Boehringer Ingelheim, said.
This launch is part of the German research-based pharma company’s ongoing mission to further scientific research and medical progress through collaboration and innovation.
Roche’s shares surge after two trial wins of its potential blockbuster drugs
Roche, which has been plagued by shrinking revenues from its
older medicines, got a shot in the arm this week with two trial wins for its cancer (Tecentriq) and hemophilia (Hemlibra) drugs. The two
drugs are potential blockbusters.
Expectedly, Roche shares surged by 6.5 percent on Monday. This added more than US$ 12 billion to the company’s market capitalization.
With Tecentriq, in combination with Avastin
and chemotherapy, Roche has posted significant gains for progression-free survival
and risk of death for a segment of lung cancer patients. Hemophilia agent Hemlibra, on the other
hand, had reduced bleeds in a new group of patients.
Tecentriq and Hemlibra, along with Roche’s multiple sclerosis medicine Ocrevus, are pillars of CEO Severin Schwan’s strategy that would offset the patent expiry of its top-selling drugs — Rituxan,
Avastin and Herceptin. Together, these three drugs account for US$ 20 billion
in annual sales.
Since lung cancer is the largest oncology market, Roche’s trial of Tecentriq, in combination with Avastin and chemo, has been closely observed. With this drug, Roche seeks to compete with rivals in cancer immunotherapy.
The mixture “provided a statistically significant and clinically meaningful reduction” in the risk of the disease worsening or death compared to Avastin plus chemotherapy in first-line treatment of advanced non-squamous non-small cell lung cancer (NSCLC), Roche said.
Concordia’s thyroid drug caught in price hike controversy in the UK
Last month, PharmaCompass had reported on a popular thyroid drug levothyroxine receiving several complaints of severe side effects from patients in France. The drug works as a stand-in for the hormone thyroxine in patients suffering from hypothyroidism, a condition that affects the body’s metabolism.
And this week, Concordia Healthcare’s thyroid drug — liothyronine — got caught in a drug price
hike controversy. An antitrust probe in the UK into Concordia’s pricing for liothyronine has found that the drug is now 57 times more expensive than it was in 2006.
Both the thyroid drugs are different compounds — while liothyronine is the synthetic form of T3-triiodothyronine,
levothyroxine is the manufactured form of T4-thyroxin. Physicians
use liothyronine instead of or in addition to levothyroxine for
patients undergoing thyroid hormone withdrawal.
Concordia Healthcare has caught the ire of watchdogs even
earlier for hikes in their drug prices. This matter only adds to the ongoing
investigations.
The UK Competition and Markets Authority (CMA) recently
levied its biggest fine ever against Pfizer and Flynn Pharma, for driving
up the price of an epilepsy drug. The fine is currently under appeal.
“Pharmaceutical companies which abuse their position and overcharge for drugs are forcing the NHS—and the UK taxpayer—to pay over the odds for important medical treatments,” CMA chief Andrea Coscelli said in a statement. “We allege that Concordia used its market dominance in the supply of liothyronine tablets to do exactly that.”
According to a statement provided to the Financial Times, Concordia said the pricing of liothyronine has been “conducted openly and transparently with the Department of Health in the UK over a period of 10 years.”
Drug industry in China hit by local law that pulls Skype out from app stores
Like several other industries, the pharmaceutical industry
relies heavily on Microsoft’s
Skype to communicate with its business partners. But this
telecommunications application can no longer be downloaded
in China, as Skype has been removed from both the Apple and Android app stores
there.
Apple said it is one of the several voice over internet
protocol (VoIP) apps which was found not to comply with the local law by the
Chinese government. Microsoft told the BBC that the app had been “temporarily removed” and the company was “working to reinstate the app as soon as possible”.
China has increased scrutiny of internet applications this year, ordering firms to remove hundreds of apps that allow users to communicate confidentially or get around China’s so-called ‘great firewall system of censorship’ to use overseas social media. According to Reuters, over the last two months, authorities have also periodically interrupted services of Facebook Inc’s encrypted messenger app WhatsApp.
Alphabet’s Google, Facebook and Twitter are unavailable to Chinese users.
According to news reports, downloaded Skype apps continue to operate. However, users will not be able to update them.
Impressions: 2265
https://www.pharmacompass.com/radio-compass-blog/amsterdam-to-host-ema-china-pulls-skype-out-of-app-stores
#PharmaFlow by PHARMACOMPASS
23 Nov 2017
This week, Phispers brings you news on how a federal judge in the US revoked ‘pharma bro’ Martin Shkreli’s bail due to his misconduct on Facebook. Roche, the world leader in oncology treatments, has to contend with more competition from biosimilars, as Amgen and Allergan’s Avastin copy bags USFDA approval. China’s Fosun Pharma tweaked its Gland Pharma buyout deal in order to avoid a review by the Indian government. And, Teva starts selling assets to reduce its debt burden.
Shkreli finally sees jail for putting a bounty on Hillary Clinton’s hair
Martin Shkreli, former CEO of Turing Pharmaceutical, an
entrepreneur and the founder of several hedge funds, was sent to jail last week, not
for the financial frauds or
for raising the sticker price of a life-saving drug (Daraprim) by 5,000 percent in 2015, but for offering US$ 5,000 for a strand of Hillary Clinton’s hair. The federal judge revoked his bail due to this misconduct on social media.
Shkreli has
been on a US$ 5 million bail, even as he is awaiting sentencing. He made two Facebook posts offering cash to anyone who could “grab a hair” from Clinton during her book tour. Shkreli has branded himself as one of social media’s ‘most notorious trolls’.
At the hearing in Brooklyn, the judge said Shkreli’s post could be perceived as a threat. And now, Shkreli (34), who called his post satire, is cooling his heels at the Metropolitan Detention Centre in Brooklyn.
Last month, Shkreli was convicted in three out of eight
charges, including securities fraud. He was scheduled to be sentenced on
January 16. Unless his lawyers prove he poses no threat to the community,
Shkreli is not likely to be released from jail.
China’s Fosun resurrects deal to buyout Gland by scaling down stake purchase
Shanghai Fosun Pharmaceutical Group has reduced the amount of stake it
wishes to buy into Indian drugmaker Gland Pharma from
86 percent to 74 percent, in order to avoid a review by the Indian government.
This way, Fosun is potentially resurrecting a
transaction that had been on hold for over a year.
Backed by Chinese billionaire Guo Guangchang, Fosun Pharma
will now buy 74 percent stake in Gland for US$ 1.09 billion, Fosun said in a
statement to the stock exchanges.
In June 2016, the Indian government had changed regulations
pertaining to foreign direct investment (FDI) in existing pharmaceutical firms
through the automatic route. Under the new rules, FDI involving more than 74 percent stake now requires an approval by the
Indian government.
The previous move, to buy 86 percent stake in Gland, would
have required an approval by the Cabinet Committee on Economic Affairs (CCEA).
The proposal was not taken up by the CCEA and was subsequently put in cold
storage during the Doklam tensions between India and China.
Hyderabad-based Gland specializes in injectable drugs such as antibiotics, oncology and cardiology treatments. Gland’s manufacturing facilities have been accepted by the US Food and Drug Administration (USFDA) and other regulatory agencies. The deal would give the Chinese firm access to Gland’s portfolio of generic injectable medicines and control of facilities to export to the US and other developed markets.
The original acquisition offer (for 86 percent stake) valued
Gland at about US$ 1.35 billion. The firm has also delayed the closing date for the
deal to October 3, from September 26.
Rise of biosimilars: Pfizer sues J&J;
Roche faces more heat from biosimilars
This
week, Pfizer filed a lawsuit against Johnson & Johnson (J&J), alleging
that J&J's contracts with health insurers for its blockbuster rheumatoid
arthritis drug, Remicade, were anticompetitive and blocked sales of Pfizer’s newly-approved biosimilar (known as Inflectra).
According
to Pfizer, J&J has signed exclusionary contracts with health insurers, hospitals and doctor groups which exclude Pfizer’s Inflectra from insurance coverage.
In the first quarter of 2017, J&J’s chief financial officer had mentioned that they saw “very little impact” from biosimilar competition to Remicade in the US.
Roche, the world’s biggest maker of oncology treatments, also has more biosimilars to contend with.
In the US, the FDA gave its nod to Mvasi (bevacizumab-awwb) as a biosimilar to
Avastin (bevacizumab) for
the treatment of multiple types of cancer. Mvasi is the first anti-cancer
biosimilar approved by the USFDA.
Amgen and Allergan’s
bevacizumab biosimilar is also undergoing review by the European Medicines
Agency (EMA). The companies are collaborating on the development and
commercialization of four oncology biosimilars.
Roche received another blow last week, when the EMA’s Committee for Medicinal Products for Human Use recommended the approval of Samsung’s Herceptin-referencing biosimilar Ontruzant. It is the first biosimilar copy of Herceptin to obtain such a backing in Europe.
In June this year, the European Commission had approved Rixathon — a biosimilar for Roche’s MabThera (or Rituximab, a
drug for blood cancer).
These approvals are expected to herald in a gradual erosion
in sales of patented cancer drugs. Rituximab, Herceptin and Avastin together
had 2016 revenue of US$ 21.8 billion. But their combined sales are expected to
fall more than 40 percent by 2022, says a forecast compiled by Thomson Reuters.
Roche needs to offset this ‘anticipated’ drop in sales by making a success of its new cancer drugs, such as Perjeta, Gazyva and Tecentriq.
Biosimilars
(medicines that are highly similar to the original drug) offer a route to more
affordable cancer care at a time when the price of modern therapies to fight
tumors is going through the roof.
Generics under pressure: Teva sells assets to reduce debt;
new M&A head at Lupin
Last week, there was finally some good news from Teva Pharmaceutical Industries, when it announced the name of Kare Schultz as its new CEO. Soon
after that, the Israeli drugmaker announced it has sold its Paragard intrauterine copper contraceptive to CooperSurgical for
US$ 1.1 billion in cash in order to bring down its debt load.
Teva will also sell the remaining assets in its specialty women’s health business for US$ 1.38 billion in two separate transactions. CVC Capital Partners Fund VI will pay US$ 703 million in cash for a portfolio in Teva’s global women’s health business including contraception, fertility, menopause and osteoporosis products.
Teva also agreed to sell its Plan B One-Step and its brands
of emergency contraception to Foundation Consumer Healthcare for US$ 675
million in cash. Combined annual net sales of these products were US$ 140 million
last year.
However, even after these sales, Teva will continue to
remain highly indebted. Last year, Teva had purchased Allergan’s generic unit for US$ 40.5 billion, taking its debt load to US$ 35 billion. Teva is actively pursuing divestitures and expects to garner at least $2 billion in total asset sales for the year.
Meanwhile, Mumbai-headquartered Lupin has
hired Jim Loerop to drive its global M&A strategy. He will also lead Lupin’s overall corporate development efforts, besides being responsible for its M&A and business development functions. Loerop joins
Lupin from Alexion Pharmaceuticals.
FDA wants
more compounding pharmacies to register under law
The USFDA Commissioner Scott Gottlieb said the agency is working on a new policy that would encourage more compounding
pharmacies to register under a law enacted in the wake of a deadly 2012
meningitis outbreak linked to one such company.
The traditional role of compounding pharmacies is to make drugs prescribed by doctors for specific patients with needs that can’t be met by commercially available drugs. Back in 2012, a compounding pharmacy known as the New England Compounding Center (NECC) had triggered a meningitis outbreak by using contaminated steroids. NECC is now defunct. But prosecutors are preparing for the second criminal trial over
contaminated steroids manufactured by NECC. Glenn Chin, a former supervisory
pharmacist at NECC, is facing trial this week for
second-degree murder and fraud. He has pleaded not guilty.
The 2012 meningitis outbreak had affected 778 patients
across the US, out of which 76 had died after receiving contaminated steroids.
After the outbreak, the US had passed the Drug Quality and
Security Act in 2013, which aimed to bring more compounding pharmacies under
the FDA (rather than under the state pharmacy boards).
The law created a category of “outsourcing facilities” that could register with the FDA, allowing them to sell products in bulk to hospitals and physician practices without prescriptions for individual patients. Today, around 70 firms have registered as outsourcing facilities.
According to the American Pharmacists Association, there are
about 7,500 pharmacies that specialize in compounding services. Gottlieb said
in order to encourage more compounders to register, the FDA would release draft
guidance in the next two months.
FDA nod for GSK’s triple drug inhaler for COPD puts it ahead of rivals
The USFDA has approved British pharma giant GlaxoSmithKline’s three-in-one inhaler — Trelegy Ellipta — for chronic obstructive pulmonary disease (COPD). This is a key new product for GSK as it
strives to keep its lead in respiratory medicine,
despite falling sales of Advair (an
asthma and COPD treatment).
Trelegy Ellipta is the first once-daily triple medicine for
COPD. The inhaler puts GSK ahead of rivals such as AstraZeneca and Novartis. GSK
developed this inhaler along with Innoviva, an
American drug company.
Last week, the inhaler, also won a recommendation for
approval from the EMA.
GSK’s CEO Emma Walmsley sees Trelegy Ellipta as one of three “critical” launches that would fill in the revenue gap left by the sagging sales of Advair, which is expected to face generic competition in the US sometime next year. Walmsley’s other two key new products are Shingrix, a shingles vaccine that was unanimously recommended for approval by a USFDA advisory panel last week, and a novel dual-drug regimen for HIV.
Impressions: 2799
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#PharmaFlow by PHARMACOMPASS
21 Sep 2017
This
week, Phispers brings you lots of regulatory news from the US, where the Trump
administration has instructed FDA to fund itself entirely through industry fees; and the agency’s chief has pledged to accelerate generic reviews through two new policies. This was yet another bad week for Teva, as it faced charges in Europe, lost a patent battle in the US to Takeda, and AstraZeneca’s CEO reportedly tossed away an offer to head it. Plus, there is news on AstraZeneca’s investment in China and Novartis’ CAR-T cell therapy for cancer.
Teva’s woes continue: Faces EC charges; loses patent battle; and Soriot drops offer
Teva’s troubles continued unabated. First, Pascal Soriot, the
chief executive of AstraZeneca, who was rumored to be the next head of
the Israeli drugmaker, decided not to leave AstraZeneca. He is reportedly forgoing an offer of a US$ 20 million bonus, and a chance to reorganize Teva, the world’s largest generic drug company.
Last week, the UK-based drug firm confirmed that Soriot would be presenting AstraZeneca’s second-quarter earnings, on July 27. Rumors of Soriot’s likely appointment were floated by an Israeli financial website. Teva is likely to announce the name of its new CEO within a month, Chaim Hurvitz, a member of Teva’s founding family, said.
Second, the European
Commission (EC) charged Teva of doing an illegal deal with Cephalon to delay selling a cheaper generic version of Cephalon’s sleep disorder drug. In the past, the EU regulator has charged scores of other companies as well, including Denmark’s Lundbeck, USA’s Johnson & Johnson and France’s Servier. According to the regulator, the pay-for-delay deals cost European consumers billions of euros.
Third, the Israeli
pharma biggie lost a patent battle in the US
appeals court to Takeda Pharmaceutical. The court said a patent on Takeda's cancer treatment — Velcade — is valid, pushing back the date when generic drug makers, including Teva and Mylan, will be allowed to launch lower-cost versions of the drug
in the US.
AZ invests US$ 79 million in Australia to cater to China’s demand for asthma drug
Air pollution is choking people in the big cities of China, raising demand for AstraZeneca’s asthma medicine — Pulmicort respules.
As a result, the British pharmaceutical giant
announced an investment of US$ 79.27 million (AUD $100 million) last week at its Sydney site which
manufactures the treatment.
The announcement was made in London on July 13, at a meeting between AstraZeneca CEO Pascal Soriot and Australia’s Prime Minister Malcolm Turnbull.
AstraZeneca will add three production lines
to the existing eight at its Sydney site, each with a capacity to produce over
70 million units of Pulmicort respules in a year. The company will bolster
exports from the site to over US$ 1.9 billion (AUD 2.4 billion) in the next
four years, with a further goal of doubling respules production to 1
billion by 2025.
“The demand for this asthma product, particularly for children in China, is immense and we see that trend continuing,” Mark Morgan, manufacturing director of AstraZeneca Australia, said.
Although labor costs are lower in China, the manufacturing technology “is difficult to replicate,” Morgan added. Over 50 percent of Pulmicort’s worldwide sales come from China. And its demand increased by 18 percent — from US$ 485 million in 2015 to US$ 570 million in 2016.
White
House tells FDA to fund itself via industry fees; FDA scouts for top talent
In the US last week, the House of Representatives passed the bill
that reauthorizes US Food and Drug Administration (FDA) to levy user fees. Soon
after that, the White House reiterated its earlier call to amend
the agreements so that the FDA is entirely funded by the medical products
industries.
In a statement, the White House said: “The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs… In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it.”
Last week’s statement said President Trump is “concerned with certain other provisions in the bill, such as those providing additional market exclusivity to manufacturers, which could make exclusivity unpredictable and decrease competition.”
Meanwhile,
the FDA
Commissioner Scott Gottlieb is
embarking on a talent hunt
to recruit new staffers for the
Prescription Drug User Fee Act (PDUFA)-related positions in the drugs and
biologics programs.
“To take on this new effort, we’re establishing a dedicated group of full-time staff with the responsibility to ensure that we reliably and predictably identify, recruit, and efficiently hire the scientific personnel the Agency needs,” Gottlieb said in his blog.
Novartis’ CAR-T cell therapy unanimously recommended for approval by FDA
The US FDA’s advisory committee has unanimously (10:0) recommended
Novartis’ CAR-T cell therapy — CTL019
(tisagenlecleucel) — for approval to treat pediatric and young adult patients with B-cell acute
lymphoblastic leukemia (ALL).
CAR-T is short for
chimeric antigen receptor T cell (CAR-T) therapy. In the US, ALL is the most
common childhood cancer.
This therapy is an immunotherapy approach to treat cancer, also considered the “fifth pillar” (after surgery, chemotherapy, radiation and targeted therapies like imatinib and trastuzumab) of cancer treatment. This approach,
called adoptive cell transfer (ACT), uses engineered immune cells to generate
remarkable responses in patients with advanced cancer.
In several early stage trials, when ACT was tested in patients with advanced ALL (with few treatment options left before these patients), many reported a complete disappearance of the cancer. And these patients remained cancer free for extended periods. Therefore, Novartis’ CTL019 assumes tremendous importance.
Meanwhile, the FDA
advisory committee also unanimously recommended Biocon/Mylan’s and Amgen’s biosimilars for approval. The two recommendations imply a
double whammy for Roche, with its drugs Avastin and Herceptin poised to get impacted by these
biosimilars.
The FDA’s Oncologic Drugs Advisory Committee (ODOC) voted 16-0 in favor of Milan’s proposed Herceptin biosimilar to treat HER2-positive breast
cancer, both for patients after surgery and for metastatic disease. The ODOC
also voted 17-0 to recommend FDA approval for Amgen’s ABP 215, an Avastin biosimilar, in each of the approved indications for the reference medication. The uses include metastatic colorectal cancer, non-squamous non-small cell lung cancer and glioblastoma.
Concord
Biotech faces GMP concerns; FDA warning letters to firms in
India, Italy
Ahmedabad-based Concord Biotech, a research and development-driven biotech firm that makes
fermentation-based APIs, was placed on Health Canada’s
Inspection Tracker due to “general GMP
observations” shared by a
regulatory partner. While no details of the observations were divulged, Health
Canada did not mention any data integrity concerns and is “continuing to review evidence submitted (i.e.
corrective actions, information from regulatory partner).”
The FDA also issued a warning letter to Tubilux Pharma SpA in Italy over concerns arising from an inspection
conducted in December 2016. The investigators raised concerns over turbulent
airflow on an aseptic processing line which “poses a significant contamination hazard” to the product. Limitations in Tubilux’s “current
equipment and process design” also
posed “a significant hazard” in the aseptic processing operation.
The warning letter also highlights that some of the products
manufactured at Tubilux were not tested for particulates prior to release.
During the inspection, FDA “observed repeated
instances of high particle count alarms during production”.
Tubilux specializes in manufacturing various types of products used in
ophthalmic applications.
A
September 2016, FDA inspection at Vista Pharmaceuticals in India highlighted concerns over the sale of
isoxsuprine hydrochloride USP, 20 mg tablets, by the firm. Although isoxsuprine
hydrochloride is sold in the US, the drug is not approved in the Orange Book.
The firm had also not validated the manufacturing process for isoxsuprine
hydrochloride USP, 20 mg tablets.
The warning letter also mentions that during the walk through of the
firm’s manufacturing
areas, FDA investigators observed that the equipment was in a state of
disrepair. “Specifically, our
investigators saw holes and corrosion in three pieces of equipment,” the letter noted.
FDA chief pledges to accelerate generic reviews through
two new policies
This week, the US FDA
Commissioner, Scott Gottlieb, made an announcement that by the end of 2017, the American
drug regulator will issue two new documents to improve the review process for
generic drugs.
These documents are
meant to streamline the submission and review of abbreviated new drug applications (ANDAs) under the FDA’s drug competition action plan.
The first document is a planned internal manual of policies and procedures (MAPP) — titled “Good ANDA Assessment Practices”. It will look to reduce “unnecessary” and “duplicative” procedures from FDA’s reviews to make them more efficient.
However, the document
will not alter any of the review goals the FDA agreed to as part of the
negotiations to reauthorize the GDUFA.
For applications that aren’t approved, MAPP will instruct reviewers to detail what needs to be fixed in the complete response letter (CRL), and provide follow up with sponsors over phone if the reasons in the letter are unclear, Gottlieb said.
The second document will be a guidance on “Good ANDA Submission Practices”. It will be added to the Center for Drug Evaluation and Research’s ‘to-do list’ for the year, which already includes 13 other new and revised draft guidances for generic drugs.
According to Gottlieb, this guidance will detail common issues found in ANDA submissions and give sponsors advice on how to avoid those issues before submitting an application.
Impressions: 3438
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#PharmaFlow by PHARMACOMPASS
20 Jul 2017
This week, Phispers brings you the latest on controversies, such as the one surrounding Hillary Clinton’s running mate Tim Kaine and Roche’s Avastin that caused vision damage in patients at an Indian hospital. There is also regulatory news from across the world, and the latest M&A deal. Did Abbott’s sales rep in India kill himself due to pressure to meet targets? An Abbott medical representative in India killed himself last week, allegedly due to the pressure put by the pharma company to achieve
periodic sales targets. As per a news report, Ashish Awasthi, 35, was found
dead on a railway track, with a note that blamed the company for his
death. Abbott, however, has denied any role in his death. In fact,
the company has said Awasthi was rated among the top performers and had
recently qualified for a training certification meant for high performers. Roche’s Avastin sent for testing, as stakeholders play blame-game in vision damage caseIndia’s Health Ministry has sent samples of Roche’s Avastin for
testing following reports that 27 out of 30 patients at the Post-Graduate
Institute of Medical Education and Research (PGIMER), Chandigarh, complained of
infection
and vision damage after being administered the drug.Samples of the drug used were sent to Central Drugs
Laboratory in Kolkata for testing. The cause of the problem remains unclear,
though the patients have been discharged
from the hospital. PGIMER suspects the problem was an outcome of the local
chemist supplying spurious drugs. This is the first
time in nine years that the hospital has purchased the medicine from a
chemist, as this time there was a delay in supply from Roche. The chemist, in
turn, passed the buck onto Roche.In a statement, Roche blamed the doctors, and said they should
not have administered the drug. “The safety of patients is always our priority and we are treating the event in Chandigarh relating to the off-label use of Avastin (bevacizumab) in the eye very seriously. Avastin is an important cancer therapy... We would like to reiterate that [it] has not been approved for use in the eye by the US FDA (Federal Drug Administration), EMA (European Medicines Agency) or the Government of India,” Roche said. Clinton’s VP nominee under scrutiny for receiving favours from Teva’s BarrWhen it comes to accepting gifts from pharmaceutical companies, doctors have invariably been the target of scrutiny. However, last week America’s presidential candidate Hillary Clinton’s running mate – Senator
Tim Kaine – received much bad press for accepting a pharma company’s offer to fly him on a private jet to a meeting in Aspen.
The company – Barr
Pharmaceutical (now a part of Teva) – flew Clinton’s pick for the US vice president in a private jet, and the flight was worth US $ 12,000, says Kaine’s disclosure report. Kaine was then the governor of Virginia. And Barr executives were lobbying Kaine to write a letter to the FDA on its behalf. Kaine signed a letter to US regulators – as requested by Barr – before taking the flight, say reports.However,
other news reports point that the flight and other gifts (worth US $ 160,000) Kaine
accepted during his stint as governor were legal under Virginia’s laws at the time, since they were disclosed. FDA rejects Valeant’s potential blockbuster drug for treating glaucomaLast week, Valeant’s
experimental glaucoma drug was rejected by the FDA, due to manufacturing
practices at its Florida facility. In a statement, Valeant said it had received a Complete Response Letter from the FDA regarding its New Drug Application for Vesneo (latanoprostene bunod) – an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. In its rejection letter, the FDA did not cite concerns over efficacy or safety of the drug, but raised unspecified deficiencies at the Florida plant operated by Valeant’s Bausch
& Lomb division. If approved, Vesneo will be the first nitric
oxide donating prostaglandin
receptor agonist available for the two disorders. Some analysts have suggested
the drug (when approved) could become a global blockbuster with more than US $ 1
billion in annual sales. FDA approves record
number of generic drug applications from IndiaAll news pertaining to Indian pharma may sound negative. But that’s not true – several new players are winning approvals to sell generics in the US market. Thought the FDA has stepped up both scrutiny and regulatory action against drug companies in India, it’s also been approving generic drug applications from India at a frenetic pace.For instance, Sun
Pharma, Glenmark
and Aurobindo
said they had received approval
to sell generics of the AstraZeneca’s blockbuster cholesterol pill Crestor in
the US.During July to December 2015, the FDA approved a record 83
new generic drug applications out of India’s publicly listed firms. And during January to June 2016, though the pace of approvals slowed down to 73, it is still amongst the best six-months in statistics for approvals going back to 2005. An off-patent malaria drug may help treat cancerAn off-patent malaria drug – Atovaquone – has been found to boost oxygen levels in the tumour cells in mice. This makes radiotherapy
more effective in treating a range of cancer, including cancer of the
lung, bowel, brain and head and neck. The drug is known to be
safe.Cancer
cells with low oxygen levels are more difficult to treat with radiotherapy, and
are more likely to spread to other parts of the body. Early
work undertaken by British scientists points that Atovaquone could help destroy
cancer cells by making them more susceptible to radiotherapy. This has prompted
the scientists to start clinical trial on the off-patent drug. China likely to be
first off-the-block to use CRISPR-Cas9 genome editing tool A long-standing goal of biomedical research is the development of an efficient and reliable way to make precise and targeted changes to the genome of living cells. Clustered regularly interspaced short palindromic repeats (CRISPR) are segments of prokaryotic DNA containing short repetitions of base sequences. And CRISPR-Cas9 – a new tool in genome editing – has created considerable excitement in biomedical research.However, it’s not the Americans who will be the first to use this tool. Scientists
in China plan to use CRISPR-Cas9 in patients as early as next month. If
they go ahead, it would be the first time people would be injected with cells
whose DNA has been altered.A US proposal to run a similar study received
approval by a federal ethics and safety panel last month, but it faces
months of additional regulatory hurdles. And the earliest it can go ahead is
2016-end.Scientists intend to use CRISPR to edit
immune-system T cells in patients with cancer in an effort to make those
cells destroy malignant cells. Novartis AG stops
making TB drugs in Pakistan due to dispute over pricingPakistan has the world’s fifth-largest incidence of tuberculosis. And fears of a health crisis – triggered by the shortage of TB drugs – looms over the country, as Novartis
AG said it has stopped making TB
drugs in Pakistan due to a dispute over pricing. The
Drug Regulatory Authority of Pakistan (DRAP) sets prices for about 320 critical
medicines. But pricing caps have not been significantly raised since 2001, and
drug companies find it unviable to make several drugs in the country. This
news comes at a time when Novartis is bracing up for a
tougher price environment in the US, post the presidential
elections. This imminent pricing environment is likely to compel the global
pharmaceutical industry to restructure. China’s Fosun to buy Gland Pharma for US $ 1.4 billionThis week, Shanghai
Fosun Pharmaceutical (Group) signed a definitive
agreement to acquire controlling stake in Hyderabad-based Gland
Pharma in a US $ 1.4 billion deal. This is the first instance of a large FDI coming into India’s manufacturing sector from China. It also paves the way for Fosun to expand its research and manufacturing capacity in India.By way
of this agreement, Fosun will acquire 86 percent stake in the company, by
buying shares held by founders Ravi Penmetsa and family and private equity
giant KKR & Company LP. KKR had bought 38 percent in Gland in November
2013, for about US $ 191 million, valuing the company at US $ 600-650 million
at the time.
Impressions: 1906
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#PharmaFlow by PHARMACOMPASS
28 Jul 2016
The year 2015 has gone down
in history as a record year for mergers and acquisitions in the pharmaceutical
and biotech space with deals worth US $ 300 billion being announced. The highlight
of the year was the Pfizer-Allergan mega-merger – the biggest-ever pharma transaction worth more than US $ 160 billion.
Pharma Letter tracked transactions
through the year and found the number of deals exceeding US $1 billion at 30 in
2015, as compared to 26 in 2014 and 20 in 2013. In all, a total of 166 M&A
deals were announced in 2015 (out of which some are yet to be completed),
compared to 137 in 2014.
This week, PharmaCompass
brings you a compilation of the top drugs of 2015 by sales revenue and growth.
Sofosbuvir – the outright winner of 2015
2015 was the year of Sofosbuvir – the revolutionary active ingredient used for the treatment of hepatitis. Together, through the sale of drugs Harvoni and
Sovaldi, Sofosbuvir brought in sales of almost US $ 19 billion.
The PharmaCompass prediction
that Harvoni (a combination of Ledipasvir and Sofosbuvir; and used for the treatment
of infectious diseases like hepatitis and HIV) would become the best-selling
drug ever in 2015 fell slightly short of expectations as its sales of US $ 13.864
billion were marginally less than AbbVie’s rheumatoid arthritis treatment – Humira.
Humira retained its place as the best-selling drug with US $
14.012 billion in sales in 2015. However, with sales growth of US $ 11.737
billion in a single year, Harvoni is poised to become the best-selling drug by
the end of 2016.
Top 20 Drugs by Sales
Here is PharmaCompass’ compilation of the best-selling drugs of 2015. This is based on information
extracted from annual reports and US Securities and Exchange Commission (SEC) filings
of major pharmaceutical companies.
If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version.
Click here to access all
the 2015 data (Excel version available) for FREE!
Product
Active Ingredient
Main Therapeutic Indication
Company
2014 Revenue in Millions
(USD)
2015 Revenue in Millions
(USD)
2015 Sales Difference
Millions (USD)
1
Humira
Adalimumab
Immunology (Organ Transplant, Arthritis etc.)
AbbVie
12,543
14,012
1,469
2
Harvoni
Ledipasvir
and Sofosbuvir
Infectious Diseases (HIV, Hepatitis etc.)
Gilead
Sciences
2,127
13,864
11,737
3
Enbrel
Etanercept
Immunology (Organ Transplant, Arthritis etc.)
Amgen / Pfizer
4,688
8,697
4009
4
Remicade
Infliximab
Immunology (Organ Transplant, Arthritis etc.)
Johnson
& Johnson / Merck
6,868
8,355
1487
5
MabThera/Rituxan
Rituximab
Oncology
Roche
5,659
7,115
1,456
6
Lantus
Insulin Glargine
Diabetes
Sanofi
6,978
7,029
51
7
Avastin
Bevacizumab
Oncology
Roche
6,481
6,751
270
8
Herceptin
Trastuzumab
Oncology
Roche
6,338
6,603
265
9
Revlimid
Lenalidomide
Blood Related Disorders
Celgene
Corpoartion
4,980
5,801
821
10
Sovaldi
Sofosbuvir
Infectious Diseases (HIV, Hepatitis etc.)
Gilead
Sciences
10,283
5,276
(5,007)
11
Seretide / Advair
Salmeterol
Respiratory Disorders
GlaxoSmithKline
6,005
5,227
(778)
12
Crestor
Rosuvastatin
Calcium
Cardiovascular
AstraZeneca
5,512
5,017
(495)
13
Lyrica
Pregabalin
Neuroscience and Mental Health
Pfizer
Inc.
5,168
4,839
(329)
14
Neulasta
Pegfilgrastim
Blood Related Disorders
Amgen
4,596
4,715
119
15
Gleevec / Glivec
Imatinib
Oncology
Novartis
4,746
4,658
(88)
16
Xarelto
Rivaroxaban
Anticoagulants
Bayer / Johnson
& Johnson
3,369
4,345
976
17
Copaxone
Glatiramer
Neuroscience and Mental Health
Teva
4,237
4,023
(214)
18
Januvia
Sitagliptin
Diabetes
Merck
& Co
3,931
3,863
(68)
19
Abilify
Aripiprazole
Neuroscience and Mental Health
Bristol-Myers
Squibb/ Otsuka
Holdings
6,485
3,804
(2681)
20
Tecfidera
Dimethyl
Fumarate
Neuroscience and Mental Health
Biogen
2,909
3,638
729
Click here to access all
the 2015 data (Excel version available) for FREE!
A year of record FDA approvals
2015 was also the
year when the US Food and Drug Administration (FDA) approved 45 novel drugs, another
all-time record high. In January this year, PharmaCompass had compiled a list of novel drugs approved by the FDA in 2015. We also extensively covered the new dosage forms of existing drugs approved in 2015. Do go through the article published on January 14, 2016, for more information.
PharmaCompass’ compilation of sales forecasts of novel drugs indicated a significant
variation in estimates. However, in our view, drugs that
saw highest sales growth in 2015 are likely to do well this year as well.
Top 20 drugs by sales growth (in USD, millions)
Product
Active Ingredient
Main Therapeutic Indication
2014 Revenue in Millions
(USD)
2015 Revenue in Millions
(USD)
2015 Sales Difference
Millions (USD)
1
Harvoni
Ledipasvir
and Sofosbuvir
Infectious Diseases (HIV, Hepatitis etc.)
2,127
13,864
11,737
2
Viekira Pak
Ombitasvir/Paritaprevir/Ritonavir
Infectious Diseases (HIV, Hepatitis etc.)
48
1,639
1,591
3
Humira
Adalimumab
Immunology (Organ Transplant, Arthritis etc.)
12,543
14,012
1,469
4
Hepatits C Franchise
Daclatasvir and Asunaprevir
Infectious Diseases (HIV, Hepatitis etc.)
256
1,603
1,347
5
Imbruvica
Ibrutinib
Chronic lymphocytic leukemia
200
1,443
1,243
6
Cubicin
Daptomycin
Anti-bacterial
25
1,127
1,102
7
Eliquis
Apixaban
Anticoagulants
774
1,860
1,086
8
Triumeq
Abacavir, Dolutegravir and Lamivudine
Infectious Diseases (HIV, Hepatitis etc.)
-
1,037
1,037
9
Xarelto
Rivaroxaban
Anticoagulants
3,369
4,345
976
10
Opdivo
Nivolumab
Oncology
6
942
936
11
Revlimid
Lenalidomide
Blood Related Disorders
4,980
5,801
821
12
Tecfidera
Dimethyl
Fumarate
Neuroscience and Mental Health
2,909
3,638
729
13
Xtandi
Enzalutamide
Oncology
480
1,207
727
14
Ibrance
Palbociclib
Oncology
-
723
723
15
Invokana / Invokamet
Canagliflozin
Type 2 diabetes
586
1,308
722
16
Victoza
Liraglutide
Diabetes
2,014
2,704
690
17
Stribild
Cobicistat, Elvitegravir, Emtricitabine and Tenofovir
Disoproxil Fumarate
Infectious Diseases (HIV, Hepatitis etc.)
1,197
1,825
628
18
Levemir
Insulin
Diabetes
2,133
2,745
612
19
Votrient
Pazopanib
Oncology
565
565
20
Perjeta
Pertuzumab
Oncology
927
1459
532
Hepatitis C products, which had three
of the four highest sales growths in 2015, clearly show the impact these
revolutionary treatments will have on the global healthcare landscape in time
to come. Cancer immunotherapy treatments, a new generation of blood thinners
and novel diabetes treatments were some of the others which demonstrated stellar
growth in 2015.
Vaccines from Pfizer and Sanofi also displayed tremendous sales growth although they
have not been included in the compilation of drugs.
Click here to access all
the 2015 data (Excel version available) for FREE!
Sign Up, Stay Ahead
While some companies like Boehringer and Valeant are yet to release their annual reports. In order to
stay informed, do sign up for the PharmaCompass
Newsletter and you will receive updated information as it becomes available
along with a lot more industry analysis.
Click here to access all
the 2015 data (Excel version available) for FREE!
CORRECTION, April 12, 2016: An earlier version of this compilation
did not account for cases where the same drug is sold by multiple companies
(e.g. Enbrel, Remicade, Xarelto etc.). As an outcome, a re-ranking of the Top
20 Drugs by Sales and Sales Growth has been done.
Impressions: 56503
https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-revenue-in-2015-who-sold-the-biggest-blockbuster-drugs
#PharmaFlow by PHARMACOMPASS
10 Mar 2016
